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Anadys Pharmaceuticals Reports Fourth Quarter and Year-End 2008 Financial Results and Highlights
Date:2/26/2009

ll-like receptor 7 (TLR7) pathway. Anadys has completed 3-month toxicology and pharmacology studies in animals that demonstrated stable induction of interferon-dependent pathways at doses that led to no adverse findings. Anadys is exploring ANA773 in two early clinical studies, one in HCV patients that is being conducted in the Netherlands and one in oncology patients that is being conducted in the United States.

  • Phase I Clinical Trial of ANA773 in HCV - Part A. In the healthy volunteer portion of the study, which concluded in late 2008, subjects received a single dose followed by four doses taken every other day, at levels from 200 mg to 1600 mg, with six subjects receiving ANA773 and two receiving placebo in each dose cohort. No serious adverse events were reported. Biomarker induction indicative of immune activation was seen in a majority of subjects beginning at 800 mg. Some side effects commonly seen with interferon treatment, including fever and chills, were observed at higher doses. The frequency and intensity of interferon-like side effects increased with dose, and one subject at the 1200 mg dose and two subjects at the 1600 mg dose discontinued from the trial before completion of dosing.
  • Phase I Clinical Trial of ANA773 in HCV - Part B. In the patient portion of the study, which commenced in October 2008, HCV infected patients received single oral doses every other day over 28 days, at doses of 800 mg, 1200 mg or 1600 mg, with six subjects receiving ANA773 and two receiving placebo in each cohort. Dosing has been completed in all three cohorts and to date we have received data for five of the six patients who received ANA773 at 1600 mg. No serious adverse events have been reported and there have been no patient discontinuations from Part B of the study. At the 800 mg and 1200 mg dose levels, minimal immune induction and no significant viral load decrease was noted. At the 1600 mg dose
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